Mitochondria and Chronic Kidney Disease

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The overarching goal of this study is to determine the role of chronic kidney disease and the activation of the kallikrein-kinin system during hemodialysis on the development of mitochondrial dysfunction; the investigators will measure mitochondrial function using the gold standard method, 31-phosphorus magnetic resonance spectroscopy.

The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial dysfunction in patients undergoing hemodialysis. The investigators will first perform a randomized, placebo-controlled, double-blind, cross-over study measuring the effect of Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Bradykinin; Icatibant

Criteria

Inclusion Criteria:

• Adult patients who have been on maintenance hemodialysis for at least 6 months

Exclusion Criteria:

• History of functional transplant less than 6 months prior to study

• Use of immunosuppressive drugs within 1 month prior to study

• History of active connective tissue disease

• History of acute infectious disease within one month prior to study

• AIDS (HIV seropositivity is not an exclusion criteria)

• History of myocardial infarction or cerebrovascular event within 3 months

• Advanced liver disease

• Gastrointestinal dysfunction requiring parental nutrition

• Active malignancy excluding basal cell carcinoma of the skin

• Ejection fraction less than 30%

• Anticipated live donor kidney transplant

• Pregnancy, breast-feeding or child-bearing potential

• History of poor adherence to hemodialysis or medical regimen

• Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies that are contraindicated in magnetic resonance imaging.

• Inability to provide consent